DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 3, 2026, has been entered.
Claim Disposition
3. Claims 1-90, 92-95, 97-99, 104-105, 107, 109-111, 115-118, 120-123, 128-129, 131, 133-135 and 143-145 have been cancelled. Claims 159-179 have been added. Claims 91, 96, 100-103, 106, 108, 112-114, 119, 124-127, 130, 132, 136-142 and 146-179 are pending. Claims 91, 96, 100-103, 106, 112-114, 119, 124-127, 130, 136-142, 146-149 and 158-179 are under examination. Claims 108, 132 and 150-157 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. The claims are only being examined to the extent that they pertain to the elected subject matter.
Claim Objections
4. Claims 91, 96, 100-103, 106, 112-114, 119, 124-127, 130, 136-142, 146-149 and 158-179 are under examination are objected to because of the following informalities:
Claim 91 and dependent hereto are objected to for the recitation of an extraneous ‘and’ following the limitations in (iii).
For clarity, precision of claim language it is suggested that claim 91 is amended to read, “……wherein the fucosyltransferase comprises an amino acid sequence [[wherein the amino acid sequence is]] at least 90% identical [[, as determined by global alignment,]] to an amino acid…..”. See also claims 114, 161-162 and 169-170 with similar language.
For clarity and consistency it is suggested that claims 101 is amended to read, “….moiety, and wherein the monosaccharide….”.
For clarity and precision of claim language it is suggested that claims 113 is amended to read, “The method of claim 112, [[wherein the method comprises]] comprising:……”.
For clarity and consistency it is suggested that claim 158 is amended to delete “according to” and instead recite “of”.
For clarity it is suggested that claim 114 is amended to recite, ‘’…..wherein the cell expresses….., wherein the fucosyltranferase….and wherein the saccharide substrate…..”. The dependent claims hereto are also included.
For clarity and precision of language it is suggested that claim 124 is amended to read, “….wherein the fucosyltransferase ….moiety, and wherein the saccharide….”.
For clarity it is suggested that claim 125 is amended to read, “……wherein the fucosyltransferase has an additional……”.
For clarity it is suggested that claim 130 is amended to read, “…wherein the fucosyltransferase……substrate, and wherein……”.
For clarity it is suggested that claim 161 is amended to read, “…wherein the fucosyltransferase…..and wherein the amino ……”. See also claim 162-167 and 176 with similar issues.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 91, 96, 100-103, 106, 112-114, 119, 124-127, 130, 136-142, 146-149 and 158-179 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. Claims 91, 96, 100-103, 106, 112-114, 119, 124-127, 130, 136-142, 146-149 and 158-179 are directed in part to a method for the production of a fucosylated compound and the does not set forth where the compound in being produced (see claim 91). It is noted that dependent claim 112 is directed to a cell-free system or a cell, however, independent claim 91 needs to stand on its own. The claimed invention is also directed to a cell metabolically engineered for producing a fucosylated compound. The art generally discloses that producing fucosylated compounds such as human milk oligosaccharides (HMO) or fucosylated proteins, typically involves engineering microorganisms like E. coli or employing enzymatic transglycoslyation. The invention is directed to engineering the product, however, the method of claim 91 does not appear to align with the engineering. The specification at page 1 discloses that the claimed invention is in the technical field of synthetic biology, metabolic engineering……. It is also disclosed that the present invention describes methods for the production of a fucoslyated compound comprising Gal-beta1-3-[Fuc-alpha1,4]-GlcNAc using a fucosylstransferase. The claimed method does not establish, how product is made, where product is made and source of fucosylstransferase. Further, the invention as claimed encompasses a large variable genus of fucosylstransferase with the recited “an amino acid”. Additionally, the claims encompasses a large variable genus of cells.
The invention encompasses a genus of fucosylated compounds that can be produced by a cell modified by any means to produce GDP-fucose and/or LNB, and wherein the fucosyltransferases can have α-1,4-fucosyltransferase activity (see claim 114 for example). In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
There is a significant amount of structural variability with respect to the members of the genus of fucosyltransferases required by the claimed method. While the specification in the instant application discloses the structure of a limited number of species of the recited genus of fucosyltransferases which are able to fucosylate LNB, it provides no clue as to the structural elements required in any fucosyltransferase that can fucosylate LNB, or the structural elements required in any α-1,4-fucosyltransferase that can fucosylate LNB and in any cell with any metabolic modifications with any lipid linkages.
The claimed invention as amended is directed to “a method of producing a fucosylated compound (see claim 91 in its entirety) and a cell metabolically engineered for producing a fucosylated compound (see claim 114 in its entirety) and the claimed invention encompasses a large variable genus of structures and cells. Regarding the method set forth in claim 91 and the dependent claims hereto as well as the cell in claim 114, they encompass a compound that comprises a large variable genus of cells and enzymes (see claim 114) that is engineered with no description of how it is modified. Thus no correlation is made between structure and function as the structure is not clearly defined or the mechanism involving the cell. The claims are not commensurate in scope with the disclosure in the specification.
The claimed invention is overly broad and encompasses a large variable genus of structures with the recitation of percent language. The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus maybe satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that new objection/rejection has been instituted for the reasons set forth above. Applicant traversed the rejection of record under 112, first paragraph and some of the same issues remain, however, the arguments were not persuasive because of the genus claims that are present in the application and applicant has not demonstrated possession of the entire genus as stated above and the amendments made were not sufficient to obviate this ground of rejection.
Conclusion
7. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5 pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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